FDA Recalls Compounded Injectable Due to Lack of Sterility Assurance
Wells Pharmacy Network is recalling Arginine/Citrulline/Ornit+Lido injectable vials due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe (Score 4), particularly when structural or significant safety defects are involved.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials. The product was compounded by Wells Pharmacy Network, LLC, located in Ocala, Florida. The recall involves 30 vials distributed nationwide.
The reason for the recall is a lack of assurance of sterility. The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 06032016@7 and 09092016@5.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 06032016@7
- 09092016@5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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